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U.S. Department of Health and Human Services

Class 2 Device Recall Architect AntiHBs Reagent

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  Class 2 Device Recall Architect AntiHBs Reagent see related information
Date Initiated by Firm August 27, 2004
Date Posted September 30, 2004
Recall Status1 Terminated 3 on July 29, 2005
Recall Number Z-1498-04
Recall Event ID 29922
Product Classification Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - Product Code LOM
Product Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Code Information list 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100 
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100 Abbott Park Rd
Abbott Park IL 60064-3502
Manufacturer Reason
for Recall		 There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.
FDA Determined
Cause 2		 Other
Action Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 8/27/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for significant differences in quantitative results for certain specimens and were instructed to discontinue use and destroy any of the affected lots remaining.
Quantity in Commerce 6,691 kits
Distribution Canada, Japan, Australia, New Zealand, Germany and England
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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